Siegfried PharmaChemikalien Minden GmbhMarch 4, 2019

FDA 483 - Siegfried PharmaChemikalien Minden Gmbh - March 04, 2019

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An FDA inspection of Siegfried PharmaChemikalien Minden GmbH in Minden, Germany, from March 4-8, 2019, revealed a significant issue in their production system. The firm was cited for failing to properly identify equipment with batch and cleaning status, including instances of undocumented cleaning. This indicates a lapse in control over manufacturing processes for API production.

Company: Siegfried PharmaChemikalien Minden Gmbh
Inspection Date: March 4, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))

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ID · 05a7d180-9d74-4cfe-bf69-aa2016b9f0e3